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FDA's MDUFA VI Draft Commitment Letter: Key Proposals and the August 7 Comment Deadline
This episode details the US FDA's newly released draft commitment letter for the sixth Medical Device User Fee Act (MDUFA VI), which will govern fiscal years 2028 through 2032. We explore the key proposals, including a significant expansion of the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, updated review performance goals, and a focus on digital health. We also highlight the critical public comment deadline of August 7, 2026, and provide practical steps for manufacturers to prepare and respond. Key Questions: - What is the MDUFA VI draft commitment letter and why is it…
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